Cardiovascular access and device delivery system

ABSTRACT

A system and method of accessing a heart of a patient is provided. A cardiac access channel is established through an apical wall of the heart to provide direct access through the apical wall to the left ventricle. A vascular access channel is established through the skin to a peripheral blood vessel. A first end of an elongate member is advanced from the outside of the apical wall through the cardiac access channel and into the left ventricle. A second end disposed opposite the first end remains outside the patient. The elongate member is drawn into and through the vascular access channel to externalize the first end of the elongate member while leaving the second end outside the apical wall of the heart.

BACKGROUND OF THE INVENTION Field of the Invention

This application is directed to systems and methods for accessing heartchambers or major blood vessels to facilitate delivering and implantingdevices or performing therapies therein.

Description of the Related Art

Catheters are in widespread use for a wide number of procedures. Inrecent years, complex devices such as aortic valves have been deliveredusing catheters. These catheter based procedures provide benefits forpatients, including reduced trauma compared to surgical techniques foraccomplishing similar outcomes, e.g., aortic valve replacement.

Limitations of catheter based techniques have spurred efforts to developa less invasive surgical technique that can be performed throughcannulae inserted into the heart through the chest wall and through anapical puncture in the heart. These procedures have advantages, such asmoving the proximal end of the tools used to perform the procedurecloser to the surgical site.

These surgical approaches provide various disadvantages, however. Forone, access to the heart through the chest wall is more complex thanaccess to a superficial peripheral vessel, such as a femoral artery. Forexample, a surgical window must still be opened to advance the surgicalcannulae through the skin and intervening tissue to the heart. To theextent large devices are delivered through this enlarged surgicalwindow, trauma to the patient is increased and closure of the heartpuncture is challenging.

SUMMARY OF THE INVENTION

The methods and systems herein provide low-profile access for creating atrans-cardiac rail with two externalized ends.

In one embodiment, a method of accessing a heart of a patient isprovided. The method can be used to provide a treatment, which mayinvolve implanting a prosthesis or other implant. A cardiac accesschannel is established through an apical wall of the heart to providedirect access through the apical wall to the left ventricle. A vascularaccess channel is established through the skin to a peripheral bloodvessel. A first end of an elongate member is advanced from the outsideof the apical wall through the cardiac access channel and into the leftventricle. A second end disposed opposite the first end remains outsidethe patient. The elongate member is drawn into and through the vascularaccess channel to externalize the first end of the elongate member whileleaving the second end outside the apical wall of the heart.

In another embodiment, a method of accessing a heart is provided.Vascular access is provided at a peripheral vein. An access catheter isadvanced through the peripheral vein, through the vena cava, and intothe heart. A distal portion of the access catheter is advanced acrossthe intra-atrial septum into the left atrium. A channel is establishedthrough a wall of the heart to provide direct access through the wall tothe left ventricle. An elongate member is advanced through the channelinto the left ventricle. The elongate member is drawn into the accesscatheter. The elongate member is tensioned between the distal portion ofthe access catheter and the channel.

In another embodiment, a method of accessing a heart is provided.Vascular access is provided at a peripheral artery. An access catheteris advanced into the aorta through the peripheral artery. In someembodiments, the access catheter passes through the brachial artery andthe left subclavian artery. In some embodiments, the access catheterpasses through a femoral artery and an iliac artery. In someembodiments, the elongate member advances antegrade from the ventricleinto the aorta. In some embodiments, the elongate member advances intothe subclavian artery or iliac artery. In at least one embodiment, theelongate member includes an atraumatic tip such as a floppy tip, a “J”tip, or a balloon tip.

In another embodiment, a method of placing a cardiovascular prosthesisis provided. A delivery system is advanced percutaneously from aperipheral blood vessel access site into the left atrium of a heart. Theleft ventricle is accessed from outside the heart through the wall ofthe heat at or adjacent to the apex of the heart by placing a sheaththerethrough. An elongate member is advanced through the sheath acrossthe aortic valve. The delivery system is linked with the elongate memberto provide a venous-arterial rail for delivery of a prosthesis into theheart and/or the aorta. A condition in the heart and/or arterialvasculature is treated over the venous-arterial rail.

In another embodiment, a device for closing a cardiac access channel isprovided. The device comprises an elongate body having a proximal endand a distal end. The proximal end has a first opening for delivering aclosure medium and a second opening for delivering a pressurizingmedium. The distal end has a first fillable member that comprises adistal face, an enclosure disposed at the distal face and extendingproximally therefrom, and one or more pores disposed through theenclosure at the distal face thereof. The first fillable member is influid communication with the first opening such that the closure mediumcan be delivered to the first fillable member. The distal end has asecond fillable member in fluid communication with the second openingsuch that the pressuring medium can be delivered to the second fillablemember. The first and second fillable members are arranged such thatwhen the first fillable member contains the closure medium and thesecond fillable member contains the pressurizing medium, the closuremedium is disposed through the pore(s).

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of this applicationand the various advantages thereof can be realized by reference to thefollowing detailed description, in which reference is made to theaccompanying drawings in which:

FIG. 1 is a cross-sectional view of a heart showing a needle placedthrough the apex of the heart into the left ventricle to provide accessto the ventricle;

FIG. 2 shows an elongate member disposed through the needle and into theleft ventricle;

FIG. 3 illustrates an introducer sheath disposed transapically over theelongate member into the ventricle;

FIG. 4 illustrates an access catheter disposed from venous vasculatureinto the heart;

FIG. 5 illustrates the elongate member illustrated in FIG. 2 engaged bya snare and drawn toward or into the access catheter of FIG. 4 toprovide a delivery platform through the mitral valve;

FIG. 6 illustrates providing a delivery platform between a direct heartaccess and one or more of a plurality of possible peripheral arterialsites,

FIG. 7 illustrates removing the introducer sheath leaving the elongatemember in place;

FIG. 8 illustrates placing a closure device over the elongate member toa position adjacent to the epicardium;

FIG. 9 illustrates one embodiment of a closure device configured tofacilitate closure of a small puncture of the apex of the heart wall;

FIG. 10 illustrates another embodiment of a closure device that includesa disc shaped balloon to reduce or eliminate bleeding through the heartwall into the pericardium;

FIG. 11 illustrates another embodiment of a closure device, having adual chamber configuration to dispense a closure medium;

FIG. 12 illustrates a configuration of the closure device of FIG. 10showing an outer chamber having a closure medium disposed therein and aninner chamber being in a low profile states;

FIG. 13 illustrates the closure device of FIG. 10 with the inner chamberin a high profile state, e.g., inflated, to enhance the pressure in theouter chamber;

FIG. 14 illustrates the closure device of FIG. 10 with the inner chamberin a further high profile state, e.g., further inflated, to cause theclosure medium to seep out of a distal face of the outer chamber;

FIG. 15-17 illustrate providing a delivery platform between peripheralvenous and peripheral arterial access sites, facilitated by direct heartaccess; and

FIGS. 18 and 19 illustrates providing two elongate members that can actas guidewire with independent maneuverability.

More detailed descriptions of various embodiments of catheter based andtransapical delivery systems, components and methods useful to treatpatients are set forth below.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

This application discloses various system and methods for providing arail structure for guiding the advancement and deployment of cardiacprostheses or therapy devices. The rail structure preferably has two ormore ends that are externalized. Externalized ends may include portionsthat are disposed outside the body, such as through percutaneousvascular access device or through direct cardiac access device.Intracorporeal lengths of the rail may be disposed between theexternalized ends. FIGS. 1-5 illustrate systems and methods that providea rail structure between a direct heart access and a peripheral bloodvessel access site. FIG. 6 shows a variation where a rail structure isdisposed between a direct heart access and a peripheral arterial access.FIGS. 7-14 illustrate systems and methods for closing a heart wallpuncture. FIGS. 15-19 illustrate systems and methods that can be used toprovide a rail between an externalized end at a peripheral venous siteand an externalized end at a peripheral arterial site. The methods andsystems of FIGS. 15-19 exploit the use of direct heart access tofacilitate various techniques.

I. Direct Heart Access to Facilitate a Venous-to-Apex orArterial-to-Apex Rail

FIGS. 1-6 illustrate a method of accessing a heart. FIG. 1 illustrates achannel 2 established through a wall of the heart to provide directaccess through the wall to the left ventricle 4. Prior to establishingthe channel 2 through the heart, surgical access is provided to theoutside of the heart. For example, a minimally invasive technique can beprovided to expose the apex of the heart. The minimally invasivetechnique may involve spreading two or more ribs to provide for directvisualization of the heart. In some embodiments, the channel 2 isestablished with a small-profile needle 6. That is, the needle 6 may beinserted from the outside of the heart through the myocardium and intothe left ventricle as shown. In at least one embodiment, the channel 2is established using an 18-gauge, beveled needle. In some embodiments,the needle 6 includes a collapsible sheath to establish the channel 2through the heart wall.

FIG. 2 shows an elongate member 10 advanced through the channel 2 intothe left ventricle 4. For example, the elongate member 10 can beinserted such that a distal end thereof is advanced through the needle 6into the ventricle as shown. The proximal end can remain outside thepatient at this stage. The elongate member 10 can be similar to a stiffguidewire. In some embodiments, the elongate member 10 has a flowdirected device such as a small balloon disposed at the distal endthereof.

FIG. 3 shows the needle 6 can be removed after the elongate member 10 isadvanced into the left ventricle 4. In some embodiments, an introducersheath or other spanning sheath 12 is fitted over the elongate member 10and advanced over the elongate member 10 until the spanning sheath 12spans across the heart wall. In some embodiments, the spanning sheath 12is a low-profile sheath. In some embodiments, the spanning sheath is a 4or a 5 French sheath. In some embodiments, the spanning sheath is16-gauge or 18-gauge. Preferably the spanning sheath 12 is configured tolimit or prevent backflow of blood out of the ventricle which is a highpressure chamber.

FIGS. 4-6 illustrate methods of vascular access, whereby an accesscatheter can be advanced from a peripheral venous site to the heart.FIG. 4 illustrates an access catheter 14 advanced through venousvascular path, e.g., from a femoral or other peripheral vein, throughthe inferior or superior vena cava, and into the heart.

FIG. 5 shows a distal portion 16 of the access catheter 14 is advancedacross the intra-atrial septum into the left atrium 20. In one method,the elongate member 10 is drawn into the access catheter 14. In someembodiments, the distal portion 16 of the access catheter 14 may includea means for capturing the elongate member 10. In at least oneembodiment, a snare 30 extends from the distal portion 16 of the accesscatheter 14 and entraps or captures the elongate member 10. The elongatemember 10 is then drawn into the access catheter 14. The elongate member10 can be tensioned between the distal portion 16 of the access catheter14 and the channel 2. Alternatively, the access catheter 14 may bemodified such as by being shortened and/or equipped with appropriatevalves to be introduced through the left atrial wall using accessmethods discussed in U.S. Patent Application Publication Number US2013/0041395, which is incorporated herein by reference. Further detailsof performing procedures using a taught platform between the accesscatheter 14 as illustrated or modified and a ventricle wall (e.g., witha base or footing deployed adjacent to an inner surface of the ventriclewall, with tines at least partially embedded in the wall, or with atrans-apical channel) are discussed in International Publication NumberWO 2014/138284, which is incorporated herein by reference.

In some embodiments, the venous-to-apex rail is used to deploy aprosthesis (not shown) to the mitral valve 25. A venous-to-apex rail isestablished as shown above in FIG. 5. Tension is applied through theelongate member 10 in the apical direction, e.g., by pulling on theproximal externalized end, to draw the prosthesis from the accesscatheter 14. In some embodiments, the prosthesis is delivered by asecond catheter (not shown), which is threaded over the venous-to-apexrail. In at least one embodiment, the venous-to-apex rail passes throughthe lumen of the prosthesis and is used to assist in seating theprosthesis onto the mitral valve 25. In some embodiments, the prosthesisis deployed between the anterior and posterior mitral valve leaflets atthe level of the mitral valve annulus. In at least one embodiment, theprosthesis is deployed by expanding a balloon within the lumen of theprosthesis to seat the prosthesis in the mitral valve annulus. In someembodiments, the prosthesis is deployed by retracting a sheath to exposethe prosthesis and to permit the prosthesis to expand into secureengagement with the mitral valve annulus.

In some embodiments, the venous-to-apex rail is used to deploy anannuloplasty ring. Annuloplasty rings are discussed in U.S. Pat. No.5,888,240, which is incorporated herein by reference. In someembodiments, an annuloplasty ring is deployed alternatively or inaddition to seating a prosthesis onto the mitral valve 25.

FIG. 6 illustrates alternative embodiment, in which a rail with twoexternalized ends is provided between the apical access site discussedabove and a peripheral artery. A path 14′ is shown, through which theelongate member 10 can travel to establish a rail that can beexternalized at a peripheral artery. An arterial access catheterdisposed at a peripheral location is advanced through the skin disposedover a peripheral artery and into the peripheral artery. In someembodiments, the arterial access catheter is introduced at a brachialartery and can be passed through the left subclavian artery 20, asillustrated in FIG. 6 by the solid line that extends through the leftsubclavian artery 20. In at least one embodiment, the arterial accesscatheter can be introduced at a femoral artery, and passed through theiliac artery 26, as illustrated in FIG. 6 by the dashed line thatextends through the iliac artery 26. In some embodiments, the elongatemember 10 is advanced antegrade into the aorta and/or into more distalarteries, to be drawn into the arterial access catheter. In someembodiments, the elongate member 10 is advanced antegrade into thesubclavian artery 20, where a snare disposed through the arterial accesscatheter couples with elongate member 10. In at least one embodiment,the elongate member 10 is advanced antegrade into the iliac artery 26,where a snare disposed through the arterial access catheter couples withelongate member 10. After the snare or other capturing device disposedthrough the access catheter couples with the elongate member 10, thedistal end of the elongate member 10 is drawn out of (e.g., externalizedat) the arterial access site.

Thus, the path 14′ defines two example routes for an apex to arterialrail structure. The route to the subclavian artery 20 is advantageous inproviding a straighter path and is more suitable for smaller and/orlower profile devices. The route to the iliac artery 26 is advantageousfor larger and/or higher profile devices that, by virtue of the railstructure provided by the elongate member 10, can easily track therelatively more tortuous path to the heart. Other peripheral sites couldbe used to externalize the distal end of the elongate member 10.

II. Closure Systems and Methods for Small-Bore Apex Access

FIGS. 7-14 show methods for closing the apical site through which theelongate member 10 entered the left ventricle 4. FIG. 7 shows that inone method the spanning sheath 12 is first removed from the apex of theleft ventricle 4. If no bleeding results after removal of the spanningsheath 12, the elongate member 10 is then removed from the heart. Insome embodiments, the myocardium is sutured at the site of apical accessto compress the tissue and close the site of apical access.

FIGS. 8-14 show methods for reducing bleeding that follows removal ofthe spanning sheath 12. FIG. 8 illustrates an embodiment where acompression member 32 is advanced over the proximal portion of theelongate member 10 until the compression member 32 contacts the heart.In some embodiments the compression member 32 includes means tointroduce biological glue onto the epicardial surface 34 of the leftventricle 4. In some embodiments, the compression member 32 is heldagainst the epicardial surface 34 for 30 seconds to 5 minutes to reducebleeding. After bleeding has been reduced, the compression member 32 iswithdrawn from epicardial surface 34 and the elongate member 10 isremoved from the heart.

FIG. 9 illustrates various configurations of the compression member 32.In some embodiments, the compression member 32 is blunt-tipped. In someembodiments, the compression member 32 is disc-shaped.

FIGS. 10-14 illustrate a device 40 for closing a cardiac access channel2. The device 40 provides for controlled dispensing of a closure mediumin the pericardium or onto the epicardium. Referring to FIGS. 11 and 12,the device 40 comprises an elongate body 42 having a proximal end 44 anda distal end 46. The proximal end 44 has a first opening 50 fordelivering a closure medium and a second opening 52 for delivering apressurizing medium. The distal end 46 has a first fillable member 54that comprises a distal face 56, an enclosure 58 disposed at the distalface 56 and extending proximally therefrom, and one or more pores 60disposed through the enclosure 58 at the distal face 56 thereof. In someembodiments, the distal face 56 has first and second traverse dimensions53, 55 that are larger than cardiac access channel to be closed. In atleast one embodiment, the first and second traverse dimensions 53, 55are at least four times the size of the cardiac access channel to beclosed. In at least one embodiment the first and second traversedimensions 53, 55 are at least 12 mm.

The first fillable member 54 is in fluid communication with the firstopening 50 such that the closure medium can be delivered to the firstfillable member 54. The distal end 46 has a second fillable member 62 influid communication with the second opening 52 such that the pressuringmedium can be delivered to the second fillable member 62. The first andsecond fillable members 54, 62 are arranged such that when the firstfillable member 54 contains the closure medium and the second fillablemember 62 contains the pressurizing medium, the closure medium isdisposed through the pore(s) 60.

III. Direct Heart Access to Facilitate a Venous-Arterial Rail

FIGS. 15-19 illustrate a method of placing a cardiovascular prosthesisthat can be used for cardiac devices and also for deploying devices inthe aorta and other large vessels close to the heart. A delivery system70 is advanced percutaneously from a peripheral blood vessel access siteinto the left atrium of a heart. The left ventricle is accessed fromoutside the heart through the wall of the heart at or adjacent to theapex of the heart by placing a spanning sheath 12 therethrough. Anelongate member 10 is advanced through the spanning sheath 12. Anarterial access catheter is introduced into or through a peripheralartery. The elongate member 10 is advanced antegrade, and is captured byor through the access catheter, for example by a snare that couples withthe elongate member 10, as described above. The elongate member 10 isdrawn into the arterial access catheter after traversing one branch ofthe path 14′ (e.g., into the subclavian or into the iliac). FIG. 16shows that the elongate member 10 is also captured by a snare or loop 72or similar structure that is extended from the distal portion 16 of theaccess catheter 14. FIG. 16 shows the delivery system 70 is linked withthe elongate member 10 to provide a venous-arterial rail for delivery ofa prosthesis into the heart and/or the aorta.

In some embodiments, the delivery system 70 accesses the left atriumthrough the left atrial wall using methods discussed in U.S. PatentApplication Publication Number US 2013/0041395, which is incorporatedherein by reference. In some embodiments, a delivery system 70 thataccesses the left atrium through the left atrial wall is used to deploya taught ventricular platform extending to a position adjacent an innerwall of the ventricle, extending to a position at least partiallyembedded in a wall about a ventricle, or extending completely through aventricle wall as in a transapical channel as discussed in InternationalPublication Number WO 2014/138284, which is incorporated herein byreference.

FIGS. 17-19 illustrate treating a condition in the heart and/or arterialvasculature over the venous-arterial rail. The loop 72 of deliverysystem 70 links to the elongate member 10. In some embodiments, thedelivery system 70 links to the elongate member 10 subsequent to theelongate member 10 coupling with the arterial access catheter. In someembodiments, the delivery system 70 links to the elongate member 10before the elongate member 10 has coupled to the arterial accesscatheter. In some embodiments, tension in the proximal end of the feedwire 74 is reduced to allow the wire 74 to extend from the deliverysystem 70 and to track along the elongate member 10 into the arterialvasculature. In the arterial vasculature, the feed wire 74 follows andmay in some cases couple with the elongate member 10 along the path 14′,as described above. Tension can be applied from outside the cardiacaccess site to the elongate member 10 to draw the feed wire 74 from thedelivery system 70 and into the ventricle 4. Further tension on theelongate member 10 can cause the prosthesis 80 (discussed below) to bedrawn out of the delivery system 70. Tension on the elongate member 10applied at a distal arterial site (e.g., on an externalized distal endof the elongate member 10 after the elongate member 10 has traversed oneof the branches of the path 14′) can draw the feed wire 74 and/or theprosthesis 80 through the aortic valve 24 and/or to the peripheralartery.

In some embodiments, a prosthesis 80 is delivered to the heart throughthe delivery system 70. In at least one embodiment, tension is appliedthrough the elongate member 10 from a proximal externalized end of theelongate member 10 in the apical direction to draw the prosthesis 80from the delivery system 70. After the prosthesis 80 enters the leftventricle 4, tension is applied to the elongate member 10 from a distalexternalized end of the elongate member 10 that has been externalizedafter following a branch of the path 14′ to draw the prosthesis 80 intoor through the aortic valve 24. Thereafter, the prostheses 80 can bedeployed in the aortic valve space or in the vasculature, e.g., in theascending aorta. In some embodiments, the prosthesis 80 is deployed inthe aortic valve annulus. In FIG. 19, the feed wire 74 extends throughthe lumen of the prosthesis 80, while the elongate member 10 is outsidethe lumen of the prosthesis 80. In some embodiments, the prosthesis 80is positioned at the aortic valve 24 and held in place while theelongate member 10 is withdrawn from the aortic valve 24. In someembodiments, the prosthesis 80 is held in place by partially deployingthe prosthesis 80. The prosthesis 80 can be self-expandable such thatwithdrawal of a sheath permits a portion or all of the prosthesis 80 toexpand. The prosthesis 80 can be secured to the elongate member 10 whilea sheath retaining the prosthesis 80 in a low-profile configuration iswithdrawn. As the sheath is withdrawn, the prosthesis 80 is permitted toexpand and does expand by virtue of an elastic or shape memory materialor member forming a part thereof. The prosthesis 80 could be mounted ona balloon or other expandable member capable of deploying the prostheses80. In some embodiments, the elongate member 10 is withdrawn from theaortic valve 24 by drawing the elongate member 10 toward the peripheralarterial access site along one of the branches of the path 14′ e.g., bypulling on the distal externalized end. In some embodiments, theelongate member 10 is withdrawn from the aortic valve 24 by disengagingthe elongate member 10 from the feed wire 74 and pulling on the proximalexternalized end of the elongate member 10 and in the apical direction.

In some embodiments, an over-the-wire catheter is used to move theprosthesis 80 along the venous-to-apex rail, along the apex-to-arterialrail, or along the venous-to-arterial rail. The rail can be pulled tightto straighten the rail in certain segments, e.g., from the heart apexthrough the aortic valve or through the mitral valve. In someembodiments, the prosthesis 80 is coupled to the feed wire 74 and pulledalong with the rail. The prosthesis 80 may be coupled to the feed wire74 by a variety of methods including releasably attaching or crimpingonto the feed wire 74 a retaining platform (not shown) that temporarilyholds the prosthesis 80 in an undeployed configuration. In other words,systems and method disclosed herein can have a first configuration ormode where a rail can be held stationary, while permitting a catheter orother device that may carry the prosthesis 80 to move relative to therail such that the catheter, device or prosthesis can be advanced orretracted over the rail. The systems and method herein can have a secondconfiguration or mode where the rail can be coupled to a catheter,device or prosthesis for no relative movement between the rail and thecatheter, device or prosthesis such that the rail can be moved throughthe patient carrying the catheter, component and/or prosthesis. Thefirst configuration can provide a direct push-pull mode. The secondconfiguration can provide an indirect push-pull mode. The secondconfiguration also enable the catheter, device or prosthesis to bepulled from distal a target site or proximal of a target site.

The prosthesis 80 may also be introduced to the heart using methods suchas those described in International Application NumberPCT/US2014/041366, which is incorporated herein by reference.

Although the present invention has been disclosed with reference tocertain specific embodiments of devices and methods, the inventorscontemplate that the invention more broadly relates to methods disclosedabove, such as those useful for orienting a catheter with respect to ananatomical structure, as well as performing diagnostic and/ortherapeutic procedures in the heart or adjacent the heart. For instance,one could place a treatment device, including a stent-graft, in theascending aorta, the aortic root, the descending aorta, or the abdominalaorta. Accordingly, the present invention is not intended to be limitedto the specific structures and steps disclosed herein, but rather by thefull scope of the attached claims.

1. A system for accessing a heart of a patient, comprising: a cardiacaccess sheath having a channel therein and a distal end configured to beadvanced through a apical wall of the heart to provide direct access viathe channel through the apical wall to the left ventricle; a vascularaccess catheter having a distal end configured to be advanced throughthe skin and into a peripheral blood vessel; and a rail having a firstend configured to be inserted into the patient through the channel ofthe cardiac access sheath or through the vascular access catheter, therail having an intermediate portion and a second end opposite the firstend, the first end configured to be disposed outside a patient through afirst percutaneous access site while the intermediate portion isdisposed in a chamber of the heart and while the second end is disposedoutside the patient through a second percutaneous access site.
 2. Thesystem of claim 1, wherein the cardiac access sheath comprises a sharpdistal portion configured to pierce the heart wall.
 3. The system ofclaim 1, wherein the intermediate portion of the rail is configured toextend from a radial artery, through the heart, to a peripheral vein. 4.The system of claim 1, wherein the intermediate portion of the rail isconfigured to extend from a femoral artery, through the heart, to aperipheral vein.
 5. (canceled)
 6. (canceled)
 7. The system of claim 1,further comprising a snare configured to be advanced within the vascularaccess catheter to be disposed distally of the distal end of thevascular access catheter to capture a portion of the rail adjacent tothe first end of the rail.
 8. A device for closing a cardiac accesschannel, comprising: an elongate body having a proximal end and a distalend; the proximal end having a first opening for delivering a closuremedium and a second opening for delivering a pressurizing medium; thedistal end having a first fillable member comprising a distal face, anenclosure disposed at the distal face and extending proximallytherefrom, and one or more pores disposed through the enclosure at thedistal face thereof, the first fillable member being in fluidcommunication with the first opening such that the closure medium can bedelivered to the first fillable member; the distal end having a secondfillable member in fluid communication with the second opening such thatthe pressuring medium can be delivered to the second fillable member;wherein the first and second fillable members are arranged such thatwhen the first fillable member contains the closure medium and thesecond fillable member contains the pressurizing medium, the closuremedium is disposed through the pore(s).
 9. The device of claim 8,wherein the second fillable member is at least partially disposed withinthe volume of the first fillable member.
 10. The device of claim 8,wherein the distal face of the first fillable member comprises an arrayof pores having first and second transverse dimension of at least fourtimes size of the cardiac access channel to be closed.
 11. The device ofclaim 8, wherein the first and second dimensions are at least 12 mm. 12.A method of accessing a heart of a patient, comprising: (a) establishinga cardiac access channel through a apical wall of the heart to providedirect access through the apical wall to the left ventricle; (b)establishing a vascular access channel through the skin to a peripheralartery; (c) advancing a first end of an elongate member from the outsideof the apical wall through the cardiac access channel and into the leftventricle, a second end disposed opposite the first end remainingoutside the patient; and (d) drawing the elongate member into andthrough the vascular access channel to externalize the first end of theelongate member outside of the peripheral artery while leaving thesecond end outside the apical wall of the heart.
 13. The method of claim12, wherein establishing the cardiac access channel comprises placing anintroducer sheath through the heart wall, the introducer sheathcomprising a lumen and having an outer profile less than 5 French. 14.The method of claim 13, further comprising removing the elongate memberand the introducer sheath; and closing the cardiac access channel. 15.The method of claim 14, wherein closing the cardiac access channelfurther comprises applying a biological glue in or adjacent to thecardiac access channel.
 16. The method of claim 15, further comprisingadvancing a balloon catheter to the epicardium and delivering thebiological glue through the balloon directly onto the epicardium. 17.The method of claim 14, wherein closing the cardiac access channelfurther comprises suturing the myocardium to compress the tissue aroundthe cardiac access channel.
 18. The method of claim 14, wherein closingthe cardiac access channel further comprises delivering a compressionmember to the epicardium to apply pressure to the tissue at or aroundthe apical wall.
 19. The method of claim 23, further comprising: (g)tensioning the elongate member to establish a delivery platform betweenthe distal portion of the access catheter and the cardiac accesschannel.
 20. The method of claim 19, further comprising delivering aprosthetic mitral valve at the level of the mitral valve annulus alongthe delivery platform after tensioning the elongate member.
 21. Themethod of claim 20, further comprising advancing a balloon cathetercarrying the mitral valve along the delivery platform to the level ofthe mitral valve annulus; and expanding the balloon to seat the valve inthe mitral valve annulus.
 22. The method of claim 20, further comprisingadvancing a catheter assembly including a sheath disposed over themitral valve along the delivery platform to the level of the mitralvalve annulus; and retracting the sheath to expose the mitral valve topermit the mitral valve to expand into secure engagement with theannulus.
 23. The method of claim 12, further comprising: (e) advancing asnare into the vasculature through the peripheral artery; and (f)drawing the elongate member through the peripheral artery using thesnare to externalize the first end of the elongate member. 24.(canceled)
 25. (canceled)
 26. (canceled)
 27. A method of placing acardiovascular prosthesis, comprising: advancing a delivery systempercutaneously from a peripheral blood vessel access site into the leftatrium of a heart; accessing the left ventricle from outside the heartthrough the wall of the heart at or adjacent to the apex of the heart byplacing a sheath therethrough; delivering an elongate member through thesheath across the aortic valve; linking the delivery system with theelongate member to provide a venous-arterial rail for delivery of aprosthesis into the heart and/or the aorta; and treating a condition ofthe aortic valve or a condition in the arterial vasculature over thevenous-arterial rail.
 28. The method of claim 27, wherein linkingcomprises snaring the elongate member from the delivery system.
 29. Themethod of claim 28, further comprising releasing the tension on theproximal end of the snare to permit the snare to track along theelongate member into the arterial vasculature.
 30. The method of claim29, further comprising externalizing the snare such that a firstguidewire can be provided from the peripheral arterial vasculature tothe peripheral venous vasculature and a second guidewire can be providedfrom an extracorporeal site directly through the heart wall to a distalend of the elongate member.
 31. The method of claim 27, wherein treatinga condition of the aortic valve or a condition in the arterialvasculature comprises deploying a stent-graft in at least one of theascending aorta, the aortic root, the descending aorta, and theabdominal aorta.
 32. The method of claim 27, wherein treating acondition of the aortic valve or a condition in the arterial vasculaturecomprises deploying an aortic valve in the aortic valve annulus.